Evidence map›Statins × lipids›PMID 21453832›Full record

Trial reportJournal of the American College of Cardiology2011

Predictors of new-onset diabetes in patients treated with atorvastatin: results from 3 large randomized clinical trials.

David D Waters, Jennifer E Ho, David A DeMicco, Andrei Breazna, Benoit J Arsenault, Chuan-Chuan Wun, John J Kastelein, Helen Colhoun, Philip Barter

Abstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of the American College of Cardiology, 2011. The graph read 2 numbers from its abstract, feeding 1 cell of the map: it favours the comparator in 1. Cited by 125 papers, 10 of them syntheses that pooled it.

2numbers the graph read from it
1cell of the map it votes in
125citing papers in PubMed, 10 pooled it
38.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

← favours the treatmentfavours the comparator →
1 · no effect
Lipidsfavours the comparator · against placebo · dyslipidemia, t2dfeeds one cell of the map
HR 1.371.08 to 1.75p = 0.011
In the SPARCL (Stroke Prevention by Aggressive Reduction in Cholesterol Levels) trial, new-onset T2DM developed in 166 of 1,905 patients randomized to atorvastatin 80 mg/day and in 115 of 1,898 patients in the placebo group (8.71% vs. 6.06%, adjusted HR: 1.37, 95% CI: 1.08 to 1.75, p = 0.011).
FeedsStatins×lipids

Read, but not usablea number the graph found but could not read as for or against

Lipidscomparator not stated · dyslipidemia, t2dfeeds one cell of the map
HR 1.190.98 to 1.43p = 0.072
In the IDEAL (Incremental Decrease in End Points Through Aggressive Lipid Lowering) trial, 239 of 3,737 patients randomized to atorvastatin 80 mg/day and 208 of 3,724 patients randomized to simvastatin 20 mg/day developed new-onset T2DM (6.40% vs. 5.59%, adjusted HR: 1.19, 95% CI: 0.98 to 1.43, p = 0.072).
FeedsStatins×lipids

clause the extractor read what became the number

2 · Its place on the map

Where it lands on the map

Rows are treatments, columns are outcomes. The coloured squares are the cells this paper feeds, coloured by the vote it casts there. Click one to jump to what this paper adds to it.

supports the treatmentfavours the comparatorno clear differenceread, but no usable result
3 · What it changes

What it adds to each cell

For every cell the paper feeds: the belief in the claim with and without this paper, and this paper's estimate drawn against every other readable study in the cell. The ringed dot is this paper.

Statins×lipids

ContradictsOpen on the map →What to test next →

38 readable studies in this cell: 27 favour the treatment, 5 find no difference, 6 favour the comparator.

Belief with this paper
0.50contested · 21 families support, 7 contradict · against placebo
Without it
0.78This paper moves it by −0.28. It would be replicated.
← favours the treatmentfavours the comparator →
1 · no effect
This paper · 2011
HR 1.371.08 to 1.75
The effect of a locally adapted, secondary stroke risk factor self-man…PMID 27349906 · 2016
OR 5.982.81 to 12.8
Association between lowering low-density lipoprotein cholesterol with …PMID 20543522 · 2010
HR 0.57
Cardiovascular event reduction and adverse events among subjects attai…PMID 21492764 · 2011
HR 0.760.57 to 1.00
The effects of lowering LDL cholesterol with simvastatin plus ezetimib…PMID 21663949 · 2011
IRR 0.830.74 to 0.94
Reduction in C-reactive protein and LDL cholesterol and cardiovascular…PMID 19329177 · 2009
HR 0.380.26 to 0.56
Pitavastatin effects on lipids in relation to major adverse cardiovasc…PMID 41936375 · 2026
RR 0.320.30 to 0.34
4 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

5 · Its place in the literature

Who cites it

125 citing papers in PubMed, 10 syntheses or guidelines pooled it, 329 citations in OpenAlex.

  1. Guideline
  2. Pooled it
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  9. Statins for the primary prevention of cardiovascular disease.The Cochrane database of systematic reviews · 2013 · on this map
    Pooled it
  10. Guideline
  11. Trial
  12. Statins Are Associated With Increased Insulin Resistance and Secretion.Arteriosclerosis, thrombosis, and vascular biology · 2021 · on this map
    Trial
  13. Trial
  14. Trial
  15. Trial
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65 more citing papers are in PubMed but not listed here.

6 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

7 · Who and what money

Authors and funding

9 authors at 5 institutions in 4 countries.

David D WatersDivision of Cardiology, San Francisco General Hospital, and University of California at San Francisco, San Francisco, California 94114, USA. dwaters@medsfgh.ucsf.edu
Jennifer E Ho
David A DeMicco
Andrei Breazna
Benoit J Arsenault
Chuan-Chuan Wun
John J Kastelein
Helen Colhoun
Philip Barter
Pfizer (United States) · USAmsterdam UMC Location University of Amsterdam · NLSan Francisco General Hospital · USThe Heart Research Institute · AUUniversity of Dundee · GB

Funding

No grant is acknowledged in the PubMed record.

8 · The paper itself

Abstract

The marked sentences are the ones the graph read a number from.

objectivesWe sought to examine the incidence and clinical predictors of new-onset type 2 diabetes mellitus (T2DM) within 3 large randomized trials with atorvastatin.

backgroundStatin therapy might modestly increase the risk of new-onset T2DM.

methodsWe used a standard definition of diabetes and excluded patients with prevalent diabetes at baseline. We identified baseline predictors of new-onset T2DM and compared the event rates in patients with and without new-onset T2DM.

resultsIn the TNT (Treating to New Targets) trial, 351 of 3,798 patients randomized to 80 mg of atorvastatin and 308 of 3,797 randomized to 10 mg developed new-onset T2DM (9.24% vs. 8.11%, adjusted hazard ratio [HR]: 1.10, 95% confidence interval [CI]: 0.94 to 1.29, p = 0.226). In the IDEAL (Incremental Decrease in End Points Through Aggressive Lipid Lowering) trial, 239 of 3,737 patients randomized to atorvastatin 80 mg/day and 208 of 3,724 patients randomized to simvastatin 20 mg/day developed new-onset T2DM (6.40% vs. 5.59%, adjusted HR: 1.19, 95% CI: 0.98 to 1.43, p = 0.072). In the SPARCL (Stroke Prevention by Aggressive Reduction in Cholesterol Levels) trial, new-onset T2DM developed in 166 of 1,905 patients randomized to atorvastatin 80 mg/day and in 115 of 1,898 patients in the placebo group (8.71% vs. 6.06%, adjusted HR: 1.37, 95% CI: 1.08 to 1.75, p = 0.011). In each of the 3 trials, baseline fasting blood glucose, body mass index, hypertension, and fasting triglycerides were independent predictors of new-onset T2DM. Across the 3 trials, major cardiovascular events occurred in 11.3% of patients with and 10.8% of patients without new-onset T2DM (adjusted HR: 1.02, 95% CI: 0.77 to 1.35, p = 0.69).

conclusionsHigh-dose atorvastatin treatment compared with placebo in the SPARCL trial is associated with a slightly increased risk of new-onset T2DM. Baseline fasting glucose level and features of the metabolic syndrome are predictive of new-onset T2DM across the 3 trials.

Indexed as

AdultAgedAtorvastatinDiabetes Mellitus, Type 2FemaleForecastingHeptanoic AcidsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsIncidenceMaleMiddle AgedPyrrolesRisk FactorsAtorvastatinHeptanoic AcidsHydroxymethylglutaryl-CoA Reductase InhibitorsPyrroles

Identifiers

PMID21453832
OpenAlexW29474508

What Socratic holds

Texttitle and abstract
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.